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NCT05263999 (Itolizumab in Acute Graft Versus Host Disease): BVCT ex-ante prediction vs. reported outcome

On 18 Feb 2024, BioinvestGPT's BVCT predicted technical success and commercial partial success for this trial. The 27 Mar 2025 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically partially significant and commercially maybe sufficient.

Clinical Trial

NCTID
NCT05263999
Acronym
EQUATOR
Drug Name
Itolizumab
Drug MoA
anti-CD6 inhibitor
Drug Modality
monoclonal antibody
Drug Class
First-In-Class
Therapeutic Area
Immune System Diseases
Indication
Acute Graft Versus Host Disease (aGVHD)
Human Patients
158
Sponsor
Equillium
Phase
Phase 3

Prediction of , index 847

Prospective Prediction
Prediction Index
847
Prediction Date
Commercial Prediction
partial SUCCESS (commercially maybe sufficient additive clinical benefit)
Technical Prediction
SUCCESS (statistically significant yet moderate additive clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
403 days in advance
Readout Data Interpretation
itolizumab + corticosteroids met several key secondary endpoints (CR) at day 99 yet failed to meet primary endpoint (CR) at day 29 compared with corticosteroids monotherapy
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically partially significant and commercially maybe sufficient
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Multicenter Study of Itolizumab in Combination With Corticosteroids for the Initial Treatment of Acute Graft Versus Host Disease
Phase
Phase 3
Status
Terminated
Enrollment
158
Lead sponsor
Equillium
Conditions
Graft Versus Host Disease; GVHD; Acute-graft-versus-host Disease; Acute GVHD; aGVHD
Interventions
BIOLOGICAL: Itolizumab; DRUG: EQ001 Placebo
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2022-04-29
Primary completion
2025-04-22
Completion
2025-05-12
Primary outcomes
  • The efficacy of itolizumab versus placebo as initial therapy for aGVHD in combination with corticosteroids in achieving early disease response. (Day 29)

NCT05263999 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials